Precious Metals

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CYTR has great news out today!

Up 13.46% today

http://www.cytrx.com/

LOS ANGELES, Dec. 19, 2019 /PRNewswire/ -- CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company, today highlighted Orphazyme A/S received FDA Breakthrough Therapy Designation for arimoclomol for NPC. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy.

(PRNewsfoto/CytRx Corporation)
(PRNewsfoto/CytRx Corporation)
Orphazyme also announced they have received Fast Track status from the FDA for arimoclomol in sIBM. This is their second Fast Track Designation for arimoclomol, which CytRx licensed to Orphazyme in 2011. Receiving the designation on multiple occasions shows the significant potential of arimoclomol in orphan diseases.

Arimoclomol has been shown to have a clinically meaningful effect on disease progression in NPC that is further supported by a biomarker effect indicating an effect on the biological underpinnings of the disease and a favorable safety and tolerability profile. Orphazyme is committed to bringing this product to patients as soon as possible. Breakthrough Therapy Designation is designed to expedite the development and review of products for serious diseases with the direct involvement of senior staff at Orphazyme working closely with the FDA to further advance arimoclomol. Preparations for filing in the U.S. are underway and the company has indicated it is on track to submit a New Drug Application in H1 2020.

"It is very gratifying to see the advances being made with arimoclomol, which CytRx developed and licensed to Orphazyme. We expect that patients who are diagnosed with these serious orphan diseases will soon have a treatment with arimoclomol," said Eric Curtis, President and Chief Operating Officer of CytRx.

CytRx has an agreement with Orphazyme that will pay CytRx up to $120 million in milestones, plus single and double-digit royalties for arimoclomol.

ImmunityBio, Inc. ("ImmunityBio") announced Results of its Landmark Trial of First-in-Human Natural Killer Cell Combination Immunotherapy with Durable, Complete Response Data and 78% Disease Control in Refractory Triple Negative Breast Cancer at the San Antonio Breast Cancer Symposium. This immunotherapy includes CytRx's aldoxorubicin as part of its innovative chemoradiation therapy.

"We are very pleased to see aldoxorubicin being utilized in this promising protocol for triple negative breast cancer patients who so desperately need advances in therapy to fight their disease," said Eric Curtis, President and Chief Operating Officer of CytRx.

CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to ImmunityBio in July 2017. CytRx has an agreement with ImmunityBio that will pay CytRx up to $343 million in milestones, plus single and double-digit royalties for aldoxorubicin.

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Good luck to all!